Skip to content

Effect of an Intervention Program of Adapted Physical Activity Combined With Compensatory Nutrition in Patients With Constitutional Thinness

Effect of an Intervention Program of Adapted Physical Activity Combined With Compensatory Nutrition in Patients With Constitutional Thinness

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06894043
Acronym
ANIMATION
Enrollment
62
Registered
2025-03-25
Start date
2025-07-07
Completion date
2026-06-30
Last updated
2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constitutional Thinness

Keywords

Constitutional thinness (CT), Adapted Physical Activity, Compensatory nutrition, Lean and muscle mass gain, Resistance to gain weight

Brief summary

Constitutional Thinness (CT) is a form of stable thinness without malnutrition but with resistance to weight gain, affecting approximately 1% of the general population. The clinical consequences are numerous and the pathophysiology remains poorly understood. Currently, conventional management involves a high-calorie and frequent diet, combined with the avoidance of endurance physical activity, although there is no significant evidence of its effectiveness. Our hypothesis is that an adapted physical activity program (APA) combined with compensatory nutrition (CN) could help these patients gain lean mass (muscle mass).

Interventions

The APA intervention will consist of a 2-week running-in period, followed by a period of adapted physical activity (APA) for 8 weeks.

BEHAVIORALCompensatory Nutrition (NC)

The Compensatory Nutrition (NC) intervention will consist of a 2-week running-in period, followed by a period of compensated nutrition (NC) for 8 weeks.

Sponsors

Laboratoire Interuniversitaire de Biologie de la Motricité
CollaboratorOTHER
Target Tape
CollaboratorINDUSTRY
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Gender: Female * BMI: ≤ 18.5 kg/m² * Weight Stability: Stable weight for at least 3 months * Age: 18 to 50 years old at the inclusion visit * Diagnosed with Constitutional thinness

Exclusion criteria

* Pregnancy, Parturition, or Lactation * Legal Restrictions: Individuals deprived of liberty, involuntarily hospitalized, or hospitalized for reasons other than research purposes, adults under legal protection (guardianship or curatorship) or unable to provide consent * Eating Disorders: Individuals with eating disorders (DSM IV and 5 criteria) * Excessive Alcohol Consumption: Consumption exceeding the equivalent of 10 glasses of wine per week * Severe Progressive Conditions: Progressive severe conditions (e.g., diabetes) * Intense Physical Activity: Individuals engaging in intense physical activity (\> 3 sessions per week) * Heavy Smoking: Significant smoking (\>10 cigarettes per day) * Psychiatric Conditions: Presence of depressive or psychiatric conditions requiring antidepressant or psychotropic treatment * Medical or Surgical History: Medical or surgical history deemed incompatible with the study by the investigator * MRI Contraindication: Individuals with contraindications to MRI will not undergo spectro-MRI analyses

Design outcomes

Primary

MeasureTime frameDescription
Lean body massFrom day 1 to week 8Lean body mass gain (kg) measured by bioimpedance

Secondary

MeasureTime frameDescription
BMIFrom day 1 to week 8Body masse index : ratio between weight and height
Energy balanceFrom day 1 to week 8Ratio between calorie intake and calorie expenditure Caloric intake measured by dietary records over 2 weeks (calorie); Calorie expenditure: Resting metabolism measured by indirect calorimetry (kcal/24h); + Postprandial thermogenesis measured by indirect calorimetry (kcal/24h);; + Physical activity energy expenditure measured by connected watch (kcal/24h);
Physical exercise capacityFrom day 1 to week 8Changes in VO2max
Quality of life SF-12 questionnaireFrom day 1 to week 8SF-12 questionnaire; Self-measurement questionnaire SF-12 (Short Form Health Survey 12); comprising 12 questions assessing 8 dimensions, namely physical functioning, role limitation due to physical problems, role limitation resulting from emotional problems, vitality (energy/fatigue), emotional well-being, social functioning, bodily pain, and perception of general and mental health; each dimension is represented by a score ranging from 0 to 100, with a low score signifying poor health perception in the dimension considered, and a high score signifying the opposite);

Countries

France

Contacts

Primary ContactNatacha GERMAIN, PhD
natacha.germain@chu-st-etienne.fr(0)477120621
Backup ContactFlorence RANCON, Cheffe de projet
florence.rancon@chu-st-etienne.fr(0) 477829458

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026